Design - LEA
Multicenter, randomized study to evaluate the efficacy and safety of Bevacizumab in combination with endocrine treatment compared to endocrine treatment alone, in postmenopausal women with advanced or metastatic breast cancer with indication of hormontherapy as first-line treatment
Treatment
The patients will be randomized to receive one of the following treatment arms:
- Group A: 1st line endocrine treatment with letrozole 2.5mg orally/day or fulvestrant 250mg i.m. injection every 4 weeks according to manufactures recommendation
- Group B: 1st line endocrine treatment with letrozole or fulvestrant and bevacizumab: 15 mg/Kg i.v. on day 1 every 3 weeks.
In group B, Bevacizumab will be administered every 21 days (day 1 of cycle 2 will be day 22 of the treatment).
The patients will receive the assigned treatment until the progression of the disease, unacceptable toxicity or withdrawal of the consent. Those patients in treatment with bevacizumab who end the study without having progressed will continue to receive the drug out of the study.
Main Objective
To compare the progression-free survival (PFS) between both treatment arms.
Secondary Objectives
To compare the following parameters between both treatment arms:
- Overall survival (OS)
- Time to treatment failure (TTF)
- Better response to treatment (RR)
- Response duration (RD)
- Clinical benefit proportion (CBP = CR + PR + SD > 6 months)
- Safety and tolerance
Tertiary Objectives
Biomarkers to investigate the efficacy, safety and action mechanism of bevacizumab, and potential interactions between the tumor expression of VEGFA/VEGFR (KDR-1) and hormone receptor processes will be studied.
Primary Endpoint
Any progression of disease or disease related death.